Useful Searches

Akloma Tinnitus AB (company behind Antinitus) threatened legal action against our non-profit organization due to some of our members expressing their opinion of Antinitus being a scam in the original discussion thread.

While we admit no liability whatsoever in relation to the allegations made, to bring matters to closure and to avoid lengthy and what we feel completely unnecessary legal proceedings, we decided to show a gesture of good will by complying with their request to delete the earlier thread.

In this new thread, let's have a constructive discussion about the company and the product.

A transparent adhesive patch is placed behind one ear. The pattern in the "matrix" is supposed to "convert ordinary, chaotic light into fractal light that affects water molecules ... into a coherent organisedstate with natural fractal order". This so called "organizing" of the body's water is somehow supposed to help against tinnitus. For some unspecified reason the "matrix" in the patch apparently wears out since a new patch must be put on every day for several weeks.http://www.antinitus.com/how-it-works/

It is true that there has been two small clinical trials, but no publication in any peer reviewed journal so far. In my opinion it was shameful that they got ethical permission to do the trials since it is such an obvious waste of time for the participating tinnitus patients.

In it's advertising the company claim to have official approval, but all they have is the lowest level of permission for medical devices, a certificate of registration where they have made a simple declaration that the product is not harmful. But it is harmful. To the patients' wallet.http://www.akloma.com/new_CE_Certification_2015.pdf

The Antinitus patch is not for sale in North America or the Scandinavian countries. I believe this is because these countries have stronger protection for consumers, or stronger regulations of medical products. I have been informed by the Advertising Standard Authority in UK that they "received a complaint from a UK consumer about advertising by this company that appears on its website, and the complaint has been referred by the ASA to the Swedish self-regulatory body". Unfortunately this leads nowhere since the "Swedish ASA" Reklamombudsmannen only deals with advertising aimed at Swedish consumers, and the patch is not for sale in Sweden... Catch 22.

I have been blogging about this sad (but also comical) story since 2012, and the latest news is that the company Akloma has been acquired by another Swedish company, Paradox Entertainment, which is listed on the stock exchange First North/Nasdaq. While I do think the inventor is sincere (but wrong), I'm not so sure about the doctors and other members of the board.

Below You can find links to my Swedish blog. I'm afraid that GoogleTranslate is not that good at Swedish.

A transparent adhesive patch is placed behind one ear. The pattern in the "matrix" is supposed to "convert ordinary, chaotic light into fractal light that affects water molecules ... into a coherent organisedstate with natural fractal order". This so called "organizing" of the body's water is somehow supposed to help against tinnitus. For some unspecified reason the "matrix" in the patch apparently wears out since a new patch must be put on every day for several weeks.http://www.antinitus.com/how-it-works/

It is true that there has been two small clinical trials, but no publication in any peer reviewed journal so far. In my opinion it was shameful that they got ethical permission to do the trials since it is such an obvious waste of time for the participating tinnitus patients.

In it's advertising the company claim to have official approval, but all they have is the lowest level of permission for medical devices, a certificate of registration where they have made a simple declaration that the product is not harmful. But it is harmful. To the patients' wallet.http://www.akloma.com/new_CE_Certification_2015.pdf

The Antinitus patch is not for sale in North America or the Scandinavian countries. I believe this is because these countries have stronger protection for consumers, or stronger regulations of medical products. I have been informed by the Advertising Standard Authority in UK that they "received a complaint from a UK consumer about advertising by this company that appears on its website, and the complaint has been referred by the ASA to the Swedish self-regulatory body". Unfortunately this leads nowhere since the "Swedish ASA" Reklamombudsmannen only deals with advertising aimed at Swedish consumers, and the patch is not for sale in Sweden... Catch 22.

I have been blogging about this sad (but also comical) story since 2012, and the latest news is that the company Akloma has been acquired by another Swedish company, Paradox Entertainment, which is listed on the stock exchange First North/Nasdaq. While I do think the inventor is sincere (but wrong), I'm not so sure about the doctors and other members of the board.

Below You can find links to my Swedish blog. I'm afraid that GoogleTranslate is not that good at Swedish.

Antinitus has been receiving a lot of publicity lately, especially via social media. There is no evidence that it works, and it has been around for some time. The packaging in small print says “clinicially demonstrated” not “clinically proven” and we have not received details of the claimed evidence from the manufacturers despite a request from our Chief Executive.

Unfortunately, any medical problem for which there is no standard cure or reliable treatment is fair game for those who wish to take advantage of people who are seeking help for their problem. Newspapers and magazines and especially the internet, routinely publish advertisements about "tinnitus relief." These ads are usually accompanied by what appears to be convincing testimonials.

* Those seeking treatment should be aware that, no matter how compelling, testimony is not evidence.
* Testimonials never indicate how many failed to find relief.
* These so-called "miracle cures" have not been scientifically tested for safety or effectiveness.

Akloma/Antinitus: Since you obviously read this thread; how come you never ever reply to critical and/or skeptic comments or questions? I asked you twice on Facebook and you blocked me AND deleted my posts. The other day I saw that someone else had linked to a website from 2012 with the exact same trial results as the ones you posted. No reply and today that had been deleted as well.

Why would we NOT think that you're fake? You've done nothing so far to prove us wrong.

The local newspaper Göteborgs-Posten made a small article about my latest blog, about this Swedish company selling questionable medical products on other markets. But I'm still hoping that other mainstream media dig into this story.

The strange patch (with the topographical matrix creating coherent light that structures body water) is now sold by the company Sensori AB (former name Paradox Entertaintment). They sold the rights to "Coonan the Barbarian" and bought Antinitus.

Use this patch while reading the Tinnitus Miracle Cure and all your troubles will be behind you.

Click to expand...

I'm not sure but I sense some sarcasm here ,i think it's hilarious how a product that is a patch gets bought by a gaming company.It's just beyond irony them threatening with legal actions is laughable (although i'm aware it's serious) A " patch " is going to cure my Tinnitus,yeah right,the explanation of how it works is like Geralt using his alchemy inventory to mix all kinds of potions and herbs.

I wrote on the Facebook page and every time I make a comment they erase it. In the Messenger of Facebook, I wrote and told them to send email proof but I get no answer, and no tracking number for more than six weeks. No one answers.

For me this is a scam and if you see on the Facebook page, all comments are asking for the product but none saying if it worked. I demand my money back, even if the product arrived. Is that understood.

They have published a small pilot trial, but since there was no control group that's not worth much.
The patches are now for sale to Swedish customers also, and I have asked the Swedish consumer protection agency to have a look at their advertising. The Medical Products Agency is already making an inquiry.

The paper Dagens Medicin (Today's Medicine) recently had a skeptical news piece about the product, but unfortunately that text not online, only in print media.

Should also mention that Tinnitus Talk is the forum they are discussing in the article but it isn't mentioned by name @Markku@Steve

Click to expand...

A translation of the article generously provided below by @Samir (thanks!).

I'm going to make some inquiries in an effort to find out what kind of data Antinitus presented (if they did - they said they were planning to in the article) at the World Tinnitus Congress (which was earlier this week).

FIRST SECTION:There is no evidence that the tinnitus patch is working

A medical patch that's claimed to relieve tinnitus is now being sold to patients in Sweden. But the critics say that there is no evidence that the product is working.

- "At first glance I think this is a little strange. I find it difficult to understand that it is allowed to sell this type of treatment without having hard evidence that it is working," says Gerhard Andersson, a tinnitus researcher and professor in clinical psychology at Linköping university.

We are talking about the Antinitus patch that's being sold directly to consumers by the Swedish company Sensori. After being aimed at foreign patients at first, there is a now a Swedish version of the site where one can order the patch at a cost of 790 Swedish crowns for a three week treatment regime.

The patch is attached behind the ear and is said to convert incidenting light into fractal light through a raster. This fractal light is in turn supposed to produce water molecules and give "biological tissue a more coherent state." According to the company's hypothesis, this "could" relieve tinnitus.

Control group missing
There is no basic scientific study published that would directly support this mechanism. But a small pilot study has recently been published where five of ten patients reported less tinnitus distress after using the patch for three weeks. According to the company, a similar result has been achieved in another study with one hundred patients that is yet to be published.

- "It is difficult to draw any conclusion from these two studies, where there is no control group and no blindfolding of the participants. I hope that the company will do a proper placebo controlled study," says Gerhard Andersson.

The company claims that there barely is any placebo effect in tinnitus treatment. Gerhard Andersson is doubtful about that.

- "My clinical experience is that there is a placebo effect in caring for the patient alone. Just because no significant placebo effects have been observed in other studies does not free the company from doing a controlled study for the treatment," he says.

Threatened to sue
In several previous blog posts, Dagens Medicins' blogger Mats Reimer has raged against the patch which he considers to be a pure scam product.

- "The company is making money off of tinnitus sufferers' inability to find another treatment. There is only one placebo effect here. As far as I understand it is the unreasonable and unproven biological principle that the patch is said to work by," says Mats Reimer, who works as a children's doctor in Mölnlycke and himself is suffering from tinnitus.

Similar criticism has also been founded on the world's largest web forum for tinnitus sufferers, the British Tinnitus Talk. But that time around, the company threatened to sue for slander.

- "They knew that we would have limited resources to defend the freedom of speech of our members. But we were fortunate to find a lawyer who worked pro bono. In the end, we found a compromise where we took away the most critical posts," says Markku Vesala, one of the founders of Tinnitus Talk.

The Swedish Medical Products Agency is investigating
Antinitus is a medical device in the lowest risk class. This means that it can be put on market with low proof requirements for its medical claims. The Medical Products Agency is now investigating the product, but the agency is not willing to comment the case until the investigation is finished after the summer.

SECOND SECTION:The Company: "We know that the patch is beneficial"
At Sensori, the founder and CEO Tommy Rönngren is upset over the statements saying that the Antinitus patch is a placebo product and that the company is using tinnitus sufferers to their advantage.

- "We are likely the biggest on tinnitus research in the world. We have invested over 100 million Swedish crowns since the year 2000. It's strange that we are receiving critique instead of applause for having a Swedish innovation that's reaching the World's height," he says.

"We know that it has effect"
Tommy Rönngren states that the patch is not a placebo and motivates that by saying that the placebo effect when tinnitus studies are concerned is very small - at least according to a review that the ENT doctor Peter Åhnblad has recently done, using eight recently published placebo controlled tinnitus studies.

Furthermore, Tommy Rönngren points out that within the studies that the company has done so far, it seems that the relief of symptoms was greatest four weeks after completing the treatment, and that one of three had a lasting relief two years after the treatment.

What evidence do you have that fractal light can affect the hearing experience?
- "Data on the mechanisms is due for publication. The mechanism is in part a hypothesis, but we know that it has effect because we see positive results in clinical studies", says Tommy Rönngren.

But your uncontrolled patient studies have very weak evidence value...
- "Two clinical studies have been conducted and a third study is in progress. All the studies have been conducted and continue to be conducted in accordance with the regulatory framework for medical device products. Evidence value is very high, just as in our post market follow ups. We will present more data on the World Tinnitus Congress in May."

How do you comment the fact that you conducted a legal process against a patient forum because critical comments were posted there?
- "We were slandered and pure inaccuracies were claimed."

Hoping for breakthrough
The turnover of Sensori for year 2016 was 1.3 million Swedish crowns while the revenue was a loss of 14.2 million Swedish crowns. According to the latest annual report, the company believes that year 2017 could be the product's commercial breakthrough.

Change will not come if we wait for some other person or some other time. We are the ones we've been waiting for. We are the change that we seek. — Barack Obama

In English: The company will carry out research, development, manufacturing and marketing within the area of biotechnology and life science, own and manage shares and other property with connection to the same and carry out other thereby compatible business.

In English: The company shall carry out research, development, manufacturing, marketing and sales of products and education within the area of biotechnology and life science, own and manage shares and other property with connection to the same and carry out other thereby compatible business.